Director CDx Development

Scorpion Therapeutics

United States

On-site

USD 200,000 - 280,000

Full time

14 days+

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Job summary

Scorpion Therapeutics is seeking a Companion Diagnostics (CDx) Lead to define and execute integrated diagnostic strategies that align with clinical development programs to enable precision oncology. You will lead biomarker and assay strategy development and oversee CDx timelines.

You will collaborate with research, regulatory, and external partners and support regulatory submissions, leveraging NGS, IHC, and FISH capabilities to drive successful approvals and biomarker-driven trials across early

Qualifications

PhD with 5+ years in clinical biomarker testing and companion diagnostics.
Experience with regulatory approvals for drugs or IVDs.
Expertise in NGS, IHC, and FISH platforms.

Responsibilities

Lead development of biomarker and assay strategies.
Collaborate with research, regulatory, and external partners.
Define diagnostic target profiles.
Support regulatory submissions (IDE/PMAs).
Oversee CDx development timelines.
Monitor industry trends.

Skills

Biomarker strategy

Cross-functional leadership

Regulatory collaboration

Strategic thinking

Education

PhD in a relevant field

Tools

NGS

IHC

FISH

Job description

Role: Companion Diagnostics (CDx) Lead

Responsible for defining and executing integrated diagnostic strategies aligned with clinical development programs to enable precision medicine.

Responsibilities

Lead development of biomarker and assay strategies
Collaborate with research, regulatory, and external partners
Define diagnostic target profiles
Support regulatory submissions (e.g., IDEs, PMAs)
Oversee CDx development timelines
Monitor industry/trends

Requirements

PhD with 5+ years in clinical biomarker testing, companion diagnostics, and successful drug or IVD approvals
Expertise in platforms like NGS, IHC, FISH
Strong leadership and cross-functional collaboration skills
Strategic thinker with excellent communication

HighValue: focus on biomarker-driven precision oncology, biomarker/diagnostic development, regulatory approval, IVD technologies, early to late-stage clinical programs, cross-functional stakeholder engagement.

WorkSetup: not specified; travel not required.

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